Cleared Traditional

K951120 - SUN-BURST

K951120 is an FDA 510(k) clearance for SUN-BURST, manufactured by Kid'S Wheel-Chairs. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K951120 · Kid'S Wheel-Chairs · Physical Medicine device
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Apr 1995
Decision
42d
Days
Class 1
Risk

K951120 is an FDA 510(k) clearance for the SUN-BURST. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Kid'S Wheel-Chairs (Kenneth City, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K951120

510(k) Number K951120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date April 10, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 116d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 422
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K951120.
MECHANICAL WHEELCHAIR- IMPACT
K945152 · Colours 'N Motion · May 1995
X2000 TRADITIONAL WHEELCHAIR
K951351 · Homecrest Industries · Apr 1995
RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
K951560 · Radius Intl., Inc. · Apr 1995
ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)
K950903 · Orthofab, Inc. · Apr 1995
ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)
K950904 · Orthofab, Inc. · Apr 1995
AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830
K951037 · Akisu Machinery · Mar 1995
K951120 · SUN-BURST
Download PDF Kid'S Wheel-Chairs